Identity
- Trade Name
- Compact Cassette Neon Pink EUDAMEDCompact Cassette - Instrument Cassette - Neon Pink - 1 Count EUDAMEDCompact Cassette FDA UDI
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- Compact Cassette Neon Pink EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMEDNeon Pink, Holds 8 instruments, Open top, rounded holes and corners allow for superior water flow compared to normal cassettes, Covers are attached to the cassette and open and fold back easily FDA UDI
- Model / Reference
- 50Z915S EUDAMEDFDA UDI
- Description
- Neon Pink, Holds 8 instruments, Open top, rounded holes and corners allow for superior water flow compared to normal cassettes, Covers are attached to the cassette and open and fold back easily FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161309761 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161309761 EUDAMED0840161300083F EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument transport trolley system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Instrument tray, reusable
Compact Cassette Neon Pink by Zirc Dental Products, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00840161309761 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161309761 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zirc Dental Products Inc.
- EUDAMED SRN
- US-MF-000021065
- Authorised Representative
- Medicom GmbH DE-AR-000005612
Sources (3)
- EUDAMED 8bcede6b-10c0-4c25-a9ea-174f87ebf728 61 fields · synced Jul 9, 2026
- EUDAMED ef6ca50c-b2d5-4684-b8cd-63c2d530046a 61 fields · synced May 19, 2026
- FDA UDI ab0985b3-b820-4906-8804-1e6038eeb343 33 fields · synced May 30, 2026